Radiation for R0?
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Thanks, Eli for your time, effort and well thought out responses (to all questions on this board). Helped me to really understand why there are so few standard protocols with CC treatments, and specifically with adjuvant tx after RO resections. Curious, Are you in the science field?
Hi Bruce,
Yes, ABC-02 is the code name of the Phase 3 study done in the UK. Here it is:
http://www.nejm.org/doi/full/10.1056/NEJMoa0908721
Note a couple of things:
1. The study found that GemCis extended survival compared to Gem alone. It did not prove that GemCis is better than any other double-agent chemo protocol such as GemOx or GemCap. GemCis became the unofficial standard of care because it’s the only protocol with a Phase 3 study behind it.
2. The study included patients with advanced disease (unresected or metastatic cases). The results of the study do not apply directly to the adjuvant setting (resected patients). Medical community extrapolates the results of ABC-02 to resected cases, but that’s really a leap of faith.
Marion – Very interesting introduction to genetic mutations and cancer for me. I’m going to have to dig into this more fully.
In reponse to Lisa’s question regarding whether they have frozen my wife’s tumor, we met with the surgeon yesterday and he told me they didn’t freeze it, but they did preserve it.
During the meeting, I asked the surgeon for his opinion regarding radiation for my wife’s condition (Intrahepatic CC with 1 hilar lymph node (R0)), which was the original question for this topic. I also inquired about the proposed chemo treatment. Now this surgeon has a PhD also, so I expected he was pretty much on top of the research in this area. He told me he didn’t think either chemo or radiation would be that helpful for my wife. He said that a few years ago nothing helped, then a study was done which said that GemCis added a couple of months to a person’s life and after that GemCis became the choice of chemo. He didn’t tell me the name of the study, but it appears it was the UK ABC-02 trial which showed that the progression-free survival for advanced or metastatic biliary tract cancer was 8.5 months for GemCis vs. 6.5 months for Gem alone.
However, when asked if my wife should undergo chemo and radiation, he said, “If its offered, take it.”
Bruce
I have learned that less than 3-10% of all cancers are caused by a genetic mutation and that not all of these mutated cancers can be targeted with drugs.
However, some physicians recommend genetic testing for those at high risk for certain cancers. We do not have a specific test for our cancer however; I believe that due to the similiarties to ovarian, breast, and pancreatic cancer some people test for the BRCA1, BRCA2 gene.
We know that cancer is the result of uncontrollable cell growth not following the orderly path of:
1. cell grows,
2. cell division,
3. cell death (apoptosis.)
A breakdown of this normal behavior leads to out of control cell growth forming a mass.
Percy’s in his posting lists the drugs used for our cancer. Additionally he mentions the specific pathway inhibitors.
I would like to point out that within the last few years researchers have focused on developing drugs that hinder the multiple signaling pathways leading to tumor growth.
For example: the epidermal growth factor receptor (EGFR) shows significant response to Erlotinib (TARCEVA) and Sorafenib (NEXAVAR.)
As Percy mentioned, most of the colon and pancreatic cancer studies transfer to our cancer. For example studies on mutations on the gene that encode KRAS may predict whether a colorectal patient will respond to a certain drug therefore, several of the KRAS clinical trials include Cholangiocarcinoma patients.
As mentioned by Eli few studies have been conducted on genetic mutations, but for our cancer there are none.
This is an interesting topic, Bruce, and I hope that in time we can continue to build on it. Better yet, it would be nice to have a researcher explain things in detail. And, that may very well happen soon.
Hugs,
MarionBruce,
Genetic mutations in CC are poorly researched. I’m not aware of a “master list” of mutations that contains all of them. At present, most clinical decisions are NOT driven by genetics.
CC patients typically receive one of the mainstream chemo protocols, such as Gem/Cis, Gem/Ox, Gem/Cap, etc. Currently there is no reliable way to determine which protocol is the best for the given patient.
Marion – That link takes me to a list of chemo agents. I searched the site for mutations and found a lot of information about them, but couldn’t find a list of them. Is there another link?
Bruce
Bruce…Several mutations have been recognized, Percy compiled the listing for us:
http://www.cholangiocarcinoma.org/punbb/viewtopic.php?id=7843
I hope this helps.
Hugs,
MarionLisa- I don’t know if they froze the tumor but I’ll sure check it out. Very interesting. I thought that all cholangiocarcinomas were the same. I didn’t realize that we could be dealing with different mutations.
Bruce
Bruce, there isn’t enough research and everyone responds differently. The 5FU worked for me and the Gem/Cis did not. We got the results back from a lab that analyzed a piece of my original tumor that had been frozen. I have two identifiable mutations so next time we should be able to use a more specific chemo that targets those mutations. Did they freeze any of your wife’s tumor for research ?
LisaEli – I did read the article about adjuvant therapy in high-risk biliary tract tumors and noticed the authors mentioned the greatest benefit for adjuvant therapy was in those people with positive lymph node disease or mcroscopic positive margins after resection. For positive lymph nodes, they stated the 5-year odds ratio was 0.49. I couldn’t find what the 5-year survival probability was for an R0 resection with a positive lymph nodes, but if it is 20%, then I calculated the 5-year probability of survival with adjuvant therapy would be 34%.
Well, that’s a start. The researchers searched for studies published from 1960 through 2010 and used 20 of these, but the article didn’t say what dates these 20 studies included. Since they are using 5-year suvival rates, I would assume that resections were done before 2005 although I suppose they may use some sort of algorithm to estimate 5-year survival rates from shorter term rates. I would think the use of old data would bias their outcomes in favor of older surgical procedures and adjuvant therapies and would hope that newer techniques and adjuvant therapies would increase these numbers.
Audry and Lisa, thank you for your comments. We just saw the Ochsner radiation oncologist today and it looks like my wife’s planned treatment is Gem/Cis for 4 month, then 5 weeks of Mon-Fri radiation with F5U. Audrey, did your doctors give you a reason for using Xyloda (Capecitabine) instead of Cisplatin? Lisa, did your doctors give you a reason for using 5FU instead of Gem/Cis? I understood that Gem/Cis was now the chemo of choice for CC.
Thanks again,
Bruce
Bruce, I am treated at the Cleveland Clinic. I had my first resection in Sept. 2010 with close margins but one lymph node in gallbladder was positive. I had 6 months of chemo(5FU) and no radiation. The cancer came back and I had another resection, during surgery they radiated the area where the two tumors were removed. I recently had two tumors radiated and it seems my tumors respond to radiation better than chemo. Since there was one positive node, I would take the chemo and radiation, if it was me…..
Lisamy husband, who had an R0 resection for ICC with “close” margins and 1 positive (celiac) lymph node, just completed his adjuvent therapy–gem/xyloda for 4 months, then 5 1/2 weeks of mon-fri radiation. Dr Gassan Abou Alfa of Sloan is his oncologist, though we also consulted with Dr. Abby Siegel of Columbia Presbyterian. Their thinking was that the positive lymph node (even just one), made this the appropriate course of action. Thankfully, my husband tolerated the whole thing pretty well.
Hi Bruce,
2000miler wrote:I checked the NCCN Guidelines Version 2.2012, Extra-2. It states “Consider fluoropyrimidine chemoradiation {f} (brachytherapy or external beam) followed by additional fluoropyrimidine or gemcitabine chemotherapy or Fluoropyrimidine based or gemcitabine based chemotherapy for positive regional lymph nodes {h}” I don’t know how to interpret that statement. Does consider apply to both part.In my (non-expert) opinion, consider applies to both parts.
Chemoradiation is used to treat positive margins and regional lymph nodes. Chemo is used to treat distant spread. Both treatments lack solid statistical evidence provided by Phase 3 clinical trials. Therefore, they have to use weasel words like “consider”.
2000miler wrote:The paper you linked to, “Adjuvant treatment in biliary tract cancer: To treat or not to treat?” states the following under Guidelines and Current Clinical Practice. “The National Comprehensive Cancer Network (NCCN) guidelines recommend only observation or adjuvant CRT with concomitant fluoropyrimidine for patients with R0 margins or negative lymph nodes and adjuvant therapy with concurrent 5-fluorouracil-based CRT followed or not by additional fluoropyrimidine or gemcitabin-based regimens in patients with R1 margins or metastic lymph nodes.” So it appears here that the NCCN is recommending CRT with or without chemo for positive lymph nodes.The paper is written by Italian doctors. Italy has a strong expertise in treating cholangiocarcinoma. However, I wouldn’t necessarily rely on their interpretation of NCCN guidelines. They may be missing some nuances of the English language. (The rest of the paper is still valuable for its discussion of adjuvant therapies)
Did you have a chance to read the second paper I linked?
Adjuvant Therapy Beneficial in High-Risk Biliary Tract Tumors: Meta-Analysis
http://www.medscape.com/viewarticle/762919They reviewed a very large sample of patients from numerous previous trials. You may need to register for a free Medscape account to read it.
2000miler wrote:Also, it appears that the recommendation is to do radiation followed by chemo, whereas what the Ocshner oncologist proposes is to do chemo followed by radiation.There is no definitive standard.
My wife did chemoradiation followed by 6 cycles of chemo. FYI, she had R1 margins and 2 positive nodes after Whipple resection of extrahepatic CC.
Susie did 3 cycles of chemo, followed by radiation, followed by another 3 cycles of chemo.
Derin (another one of our members) did chemo followed by radiation.
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